Azilect + Antidepressant Chart Review (STACCATO)

This study has been completed.

Sponsor:

Teva Pharmaceutical Industries

ClinicalTrials.gov Identifier:

NCT00955604

First Posted: August 10, 2009

Last Update Posted: February 6, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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To identify the occurrence of serotonin toxicity in Parkinson's Disease (PD) patients receiving antidepressant therapy and rasagiline, compared to those receiving rasagiline without antidepressant medications and compared to PD patients receiving antidepressants, but not rasagiline.

The frequency of serotonin toxicity, as determined by the Adjudication Committee will be calculated for each Group. The primary comparison will be Group R+AD vs. Group R and vs. Group AD [ Time Frame: 9 months ]

Group R+AD Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) for at least 14 days

Drug: Group R+AD Rasagiline + Antidepressant

Rasagiline and an antidepressant (SRIs, SNRIs, St. John's wort and/or TCAs) at least 14 days

Other Name: Azilect

Group R

At least 2 months of rasagiline

Drug: Group R Rasagiline

At least 2 months of rasagiline

Other Name: Azilect

Group AD

At least 2 months of Anti-PD and Rasagiline

Drug: Group AD Anti-PD + Antidepressant

An approved dopaminergic medication for PD. (2 months of treatment with an antidepressant medication.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

Male or female patients with a diagnosis of PD:

who received rasagiline at any dose, as mono- or adjunct therapy for PD, with concomitant antidepressant medication, OR

who received rasagiline at any dose, as mono- or adjunct therapy for PD, without concomitant antidepressant medication, OR

Rasagiline treatment as mono- or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono- or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period

Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required

Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation.

In addition to the above criteria, each group has specific inclusion criteria stated below:

Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline).

Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use.

Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication.